为期 6 个月的真实世界研究:评估从 IL-23 抑制剂和其他生物疗法转用 Ixekizumab 后的疗效:CorEvitas银屑病登记。

IF 1.9 Q3 PHARMACOLOGY & PHARMACY
Drugs - Real World Outcomes Pub Date : 2024-09-01 Epub Date: 2024-06-24 DOI:10.1007/s40801-024-00439-w
Mark Lebwohl, Bruce Strober, Amy Schrader, Alvin H Li, Thomas Eckmann, Baojin Zhu, William N Malatestinic, Julie Birt, Meghan Feely, Andrew Blauvelt
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引用次数: 0

摘要

背景:之前的研究表明,CorEvitas 银屑病登记处的患者在使用生物制剂失败后又开始使用 ixekizumab,6 个月后疾病严重程度和患者报告结果均有所改善。然而,白细胞介素-23抑制剂(IL-23i)等新疗法并未被考虑在内。在此,我们利用包括IL-23i在内的最新数据,评估了ixekizumab从任何生物制剂转换而来后的6个月疗效,以及ixekizumab的6个月疗效是否会受到先前生物制剂类别的影响:我们纳入了CorEvitas银屑病注册患者,这些患者在停用另一种生物制剂治疗后开始使用ixekizumab,并在开始使用ixekizumab后进行了相应的6个月随访(N = 743,2016-2023年)。既往生物制剂类别分为肿瘤坏死因子抑制剂(TNFi)或白细胞介素-12/23抑制剂(IL-12/23i,n = 405)、非ixekizumab白细胞介素-17i(IL-17i,n = 237)或IL-23i(n = 101)。使用协方差分析(ANCOVA)计算了前几组生物制剂在体表面积(BSA)、皮肤病生活质量指数(DLQI)、瘙痒和皮肤疼痛方面的调整后平均变化。计算了所有患者的银屑病面积和严重程度指数(PASI75、PASI90和PASI100)、研究者总体评估(IGA)0/1和DLQI 0/1改善率≥75%、≥90%和≥100%的比例,并使用多变量改良泊松回归通过相对风险(RRs)和95%置信区间(CIs)对之前的生物制剂类别进行了比较:结果:从 TNFi 或 IL-12/23i 转用 ixekizumab 的患者在 BSA、DLQI、瘙痒和皮肤疼痛方面的平均改善程度分别为 7.6、3.6、23.3 和 16.7(均为 p 结论:IL-23i 和 ixekizumab 的最新研究结果表明,在 TNFi 或 IL-12/23i 治疗的患者中,IL-23i 和 ixekizumab 的治疗效果更佳:这些更新的IL-23i数据再次证实,银屑病患者在停用另一种生物制剂后改用ixekizumab治疗6个月后,疾病严重程度和患者报告结果在现实世界中均有所改善。与改用另一种IL-17i的患者相比,改用TNFi或IL-12/23i的患者更有可能达到PASI100和IGA 0/1,而改用IL-23i的患者除了PASI100和IGA 0/1外,更有可能达到PASI90。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Six-Month Real-World Study to Assess the Effectiveness of Ixekizumab After Switching from IL-23 Inhibitors and Other Biologic Therapies: The CorEvitas Psoriasis Registry.

Background: Prior work showed that patients from the CorEvitas Psoriasis Registry who had previously failed a prior biologic and then initiated ixekizumab demonstrated improvements in disease severity and patient-reported outcomes after 6 months. However, newer therapies such as interleukin-23 inhibitors (IL-23i) were not considered. Here, with more recent data including IL-23i, 6-month effectiveness of ixekizumab following a switch from any biologic was assessed as well as whether 6-month effectiveness of ixekizumab was impacted by prior biologic class.

Methods: We included CorEvitas Psoriasis Registry patients who initiated ixekizumab after discontinuing another biologic therapy and had a corresponding 6-month follow-up visit following ixekizumab initiation (N = 743, 2016-2023). Immediate prior biologic class was categorized as tumor necrosis factor inhibitor (TNFi) or interleukin-12/23 inhibitors (IL-12/23i, n = 405), non-ixekizumab interleukin-17i (IL-17i, n = 237), or IL-23i (n = 101). Adjusted mean changes in body surface area (BSA), Dermatology Life Quality Index (DLQI), itch, and skin pain were calculated for prior biologic class groups using analysis of covariance (ANCOVA). Proportions achieving ≥ 75%, ≥ 90%, and ≥ 100% improvement in Psoriasis Area and Severity Index (PASI75, PASI90, and PASI100, respectively), Investigator's Global Assessment (IGA) 0/1, and DLQI 0/1 were calculated for all patients and compared among prior biologic classes via relative risks (RRs) and 95% confidence intervals (CIs) using multivariable modified Poisson regression.

Results: Mean improvements in BSA, DLQI, itch, and skin pain, were 7.6, 3.6, 23.3, and 16.7, respectively, for ixekizumab patients who switched from TNFi or IL-12/23i (all p < 0.05); 6.8, 3.3, 19.6, and 14.1, respectively, for those who switched from non-ixekizumab IL-17i (all p < 0.05); and 7.8, 3.4, 22.2, and 12.8, respectively, for those who switched from IL-23i (all p < 0.05). Overall, 54%, 41%, and 31% of ixekizumab initiators achieved PASI75, PASI90, and PASI100, respectively, 50% maintained or achieved IGA 0/1, and 48% maintained or achieved DLQI 0/1. The prior TNFi or IL-12/23i group was 31% more likely to achieve PASI100 (RR = 1.31, 95% CI 1.01, 1.69) and 32% more likely to maintain or achieve IGA 0/1 (RR = 1.32, 95% CI 1.11, 1.57), but not significantly more likely to achieve PASI90. The prior IL-23i group was 45% more likely to achieve PASI90 (RR = 1.45, 95% CI 1.10, 1.91), 55% more likely to achieve PASI100 (RR = 1.55, 95% CI 1.12, 2.13), and 39% more likely to maintain or achieve IGA 0/1 (RR = 1.39, 95% CI 1.12, 1.73) compared to the prior non-ixekizumab IL-17i group. Achievement of PASI75 and DLQI 0/1 was consistent across the prior TNFi or IL-12/23i, IL-23i, and non-ixekizumab IL-17i groups.

Conclusions: These updated findings with IL-23i data reaffirm that patients with psoriasis who switch to ixekizumab after discontinuing another biologic demonstrate improvement in disease severity and patient-reported outcomes at 6 months in real-world settings. Compared to patients who switched from another IL-17i, patients who switched class from a TNFi or IL-12/23i were more likely to achieve PASI100 and IGA 0/1, and patients who switched class from an IL-23i were more likely to achieve PASI90 in addition to PASI100 and IGA 0/1.

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来源期刊
Drugs - Real World Outcomes
Drugs - Real World Outcomes PHARMACOLOGY & PHARMACY-
CiteScore
3.60
自引率
5.00%
发文量
49
审稿时长
8 weeks
期刊介绍: Drugs - Real World Outcomes targets original research and definitive reviews regarding the use of real-world data to evaluate health outcomes and inform healthcare decision-making on drugs, devices and other interventions in clinical practice. The journal includes, but is not limited to, the following research areas: Using registries/databases/health records and other non-selected observational datasets to investigate: drug use and treatment outcomes prescription patterns drug safety signals adherence to treatment guidelines benefit : risk profiles comparative effectiveness economic analyses including cost-of-illness Data-driven research methodologies, including the capture, curation, search, sharing, analysis and interpretation of ‘big data’ Techniques and approaches to optimise real-world modelling.
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